Drug Trial Snapshot: Xepi

The information provided in Snapshots highlights who participated in the clinical trials that supported the FDA approval of this drug, and whether there were differences among sex, race, and age groups. The “MORE INFO” bar shows more detailed, technical content for each section. The Snapshot is intended as one tool for consumers to use when discussing the risks and benefits of the drugs.

LIMITATIONS OF THIS SNAPSHOT:

Do not rely on Snapshots to make decisions regarding medical care. Always speak to your health provider about the risks and benefits of a drug. Refer to XEPI Prescribing Information for complete information.

What are the benefits of this drug (results of trials used to assess efficacy)?

The table below summarizes efficacy results for the clinical trials based on the primary efficacy endpoint defined as the proportion of patients at Day 6-7 who achieved clinical success defined as no need for additional antimicrobial therapy of the baseline affected area(s) and absence/reduction in clinical signs and symptoms using Skin Infection Rating Scale (SIRS) score.

Table 2. Clinical Response at End of Therapy in Trial 1 and Trial 2 in All Randomized Patients

Trial 1

Trial 2

XEPI

Placebo

XEPI

Placebo

(N = 155) n (%)

(N = 156)n (%)

(N = 206)n (%)

(N = 206)n (%)

Clinical success

54 (34.8)

30 (19.2)

112 (54.4)

78 (37.9)

Clinical failure

98 (63.2)

120 (76.9)

91 (44.2)

121 (58.7)

Unable to determine

3 (1.9)

6 (3.8)

3 (1.5)

7 (3.4)

XEPI Prescribing Information

Were there any differences in how well the drug worked in clinical trials among sex, race and age?

Sex: XEPI worked similarly in male and female patients.

Race: XEPI worked similarly in Black or African American and in White patients. The number of patients in other races was limited; therefore, differences in response among all races could not be determined.

Age: XEPI worked better in patients younger than 12 years of age than in older ones.

Were there any differences in side effects among sex, race and age?

Were there any differences in side effects of the clinical trials among sex, race, and age groups?

Differences in side effects in the clinical trials among sex, race, and age groups were not assessed because of the limited number of overall side effects in the trials.

WHO WAS IN THE CLINICAL TRIALS?

Who participated in the clinical trials?

The FDA approved XEPI based on evidence from two clinical trials (NCT 01397461 and NCT 02090764) of 723 patients with impetigo. The trials were conducted in the USA, Europe, South Africa and Puerto Rico.

The figure below summarizes how many males and females were in the clinical trials.

Figure 1. Baseline Demographics by Sex

FDA Statistical review

Figure 2 and Table 1 below summarize the percentage of patients by race in the clinical trials.

Figure 2. Baseline Demographics by Race

FDA Statistical review

Table 1. Baseline Demographics by Race

Race

Number of Patients

Percentage

White

382

53

Black or African American

245

34

Asian

32

4

American Indian or Alaska Native

2

less than 1

Mixed

62

9

Figure 3 summarizes the percentage of patients by age in the clinical trials.

How were the trials designed?

The benefit and side effects of XEPI were evaluated in two clinical trials of patients with impetigo. In both trials patients received treatment with either XEPI or placebo cream twice daily for 5 days. Neither the patients nor the health care providers knew which treatment was being given until after the trials were completed.

At the end of therapy, patients were evaluated for improvement of clinical signs and symptoms of impetigo and need for additional antibacterial treatment.

How were the trials designed?

The safety and efficacy of XEPI were established in 2 randomized, double-blind, placebo-controlled trials of 1 week duration. All patients with predetermined impetigo surface area were randomized 1:1 to receive XEPI or placebo cream applied twice daily for 5 days.

The primary efficacy outcome measure was the proportion of patients at the end of the treatment who achieved clinical success defined as no need for additional antimicrobial therapy of the baseline affected area(s) and absence/reduction in clinical signs and symptoms using Skin Infection Rating Scale (SIRS) score.

GLOSSARY

CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.